Pilot Study of Zoledronic Acid in Combination With First-line Chemotherapy in Aged Patients With Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Hebei Tumor Hospital
Information provided by (Responsible Party):
Hebei Tumor Hospital
ClinicalTrials.gov Identifier:
NCT01737216
First received: November 27, 2012
Last updated: December 28, 2012
Last verified: November 2012
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Purpose
Pilot study of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer. The purpose is to assess the effects of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer on bone mineral density gain in the lumbar spine and total hip.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: Zoledronic acid plus EP/TP Drug: EP/TP |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
Drug Information available for:
Zoledronic acid
U.S. FDA Resources
Further study details as provided by Hebei Tumor Hospital:
Primary Outcome Measures:
- Progression-free survival(PFS) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Overall survival(OS) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Bone mineral density(BMD) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Quality of life(QOL) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Zoledronic acid plus First-line chemotherapy |
Drug: Zoledronic acid plus EP/TP
Drug:EP/TP+Zoledronic acid EP(VP-16 100mg/m2 d1-3;DDP 60-75mg/m2 d1) every 4 weeks, for 4-6 cycles TP(PTX 135-175mg/m2 d1;DDP 60-75mg/m2 d1) every 3 weeks, for 4-6 cycles Zoledronic acid 4mg d1 every 3 months until bone metastasis, 4mg d1 every 1 month until progression
|
| Active Comparator: First-line chemotherapy |
Drug: EP/TP
Drug:EP/TP EP(VP-16 100mg/m2 d1-3;DDP 60-75mg/m2 d1) every 4 weeks, for 4-6 cycles TP(PTX 135-175mg/m2 d1;DDP 60-75mg/m2 d1) every 3 weeks, for 4-6 cycles
Other Name: First-line chemotherapy
|
Eligibility| Ages Eligible for Study: | 70 Years and older (Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Signed informed consent form
- Age ≥70 years
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
- Histologically or cytologically confirmed lung cancer
- Did not receive bisphosphonate treatment
Exclusion Criteria:
- Appear relapse and metastasis
- receive other bisphosphonate treatment
- Active or uncontrolled infection
- Pregnant or lactating women
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737216
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737216
Locations
| China, Hebei | |
| Hebei Tumor Hospital | |
| Shijiazhuang, Hebei, China, 050011 | |
Sponsors and Collaborators
Hebei Tumor Hospital
Investigators
| Principal Investigator: | Wei Liu | Hebei Tumor Hospital |
More Information
| Responsible Party: | Hebei Tumor Hospital |
| ClinicalTrials.gov Identifier: | NCT01737216 History of Changes |
| Other Study ID Numbers: | HBTH201 Hebei Tumor Hospital |
| Study First Received: | November 27, 2012 |
| Last Updated: | December 28, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Hebei Tumor Hospital:
|
Aged patients |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Zoledronic acid Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 29, 2016